Actively Recruiting
Ischemia With No Obstruction of Coronary Arteries: Underlying Mechanisms and the Impact of Exercise Training (EXINOCA)
Led by Bispebjerg Hospital · Updated on 2025-02-21
100
Participants Needed
2
Research Sites
28 weeks
Total Duration
On this page
Sponsors
B
Bispebjerg Hospital
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates coronary microvascular dysfunction (CMD) in patients experiencing chest pain without narrowing of the heart's coronary arteries, a condition known as ischemia with no obstructive coronary artery disease (INOCA). The study explores whether this reduced microvascular function also affects other body organs and whether regular aerobic exercise can improve this heart condition and symptoms. The trial aims to better understand CMD mechanisms and assess exercise training effects in these patients. Participants will be randomly assigned to one of two groups: an exercise training group or a control group. The exercise group will engage in supervised cycling sessions lasting 40-50 minutes, three times weekly for 12 weeks. These sessions include warm-up, interval cycling at varying intensities, and cool-down phases, with progressive intensity throughout the program. Home training up to once weekly is allowed if intensity levels are maintained. The control group will not receive training during the study but will be offered exercise afterward. Participants are encouraged to maintain their usual lifestyle and medications. During the study, researchers will monitor changes in coronary microvascular function using myocardial blood flow reserve measurements before and after three months. They will also assess symptoms using angina questionnaires, exercise capacity, and blood flow in skin, muscle, and fat tissue. Training sessions are closely supervised with heart rate and exertion monitoring to ensure safety and effectiveness. The total participation duration includes the 12-week intervention period with assessments at baseline and after three months.
CONDITIONS
Brief Title
Impact of Exercise Training on Ischemia With Non-Obstructive Coronary Arteries (INOCA): The ExINOCA Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Coronary microvascular dysfunction defined by myocardial blood flow reserve (MBFR) below 2.5 or hyperemic myocardial blood flow below 2.3 ml/g/min using [15O]H2O-PET
- No obstructive coronary artery disease
- Adults aged 50 years or older
- Female participants must be postmenopausal (amenorrhea for at least 1 year) or surgically sterile
You will not qualify if you...
- Females of childbearing potential who are premenopausal and capable of becoming pregnant
- Heart failure with left ventricular ejection fraction less than 40%
- Uncontrolled hypertension with blood pressure above 140/90
- Co-morbid conditions leading to less than 1 year expected survival
- Considered unsuitable for the study by the investigator for any reason
- Unable or unwilling to exercise due to conditions like arthritis or injury
- Already regularly physically active or have maximal oxygen uptake greater than 45 ml/kg/min
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants undergo supervised exercise training consisting of cycling sessions 40-50 minutes, 3 times weekly for 12 weeks. Home training once a week is allowed if participants can maintain prescribed intensity levels.
3 visits per week (supervised cycling sessions) with additional home training up to once a week
Trial Site Locations
Total: 2 locations
1
Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57, Frederiksberg, Denmark, 2000
Copenhagen, Denmark, 2400
Not Yet Recruiting
2
Frederiksberg Hospital, Dept. of Cardiology, Building 16, Y3, Nordre Fasanvej 57
Frederiksberg, Denmark, 2000
Actively Recruiting
Research Team
E
Eva Prescott, MD, DMSc
M
Mads Fischer, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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